FDA.reportPublic FDA data

MocareHealth

Primary DI
36971384153956
Brand
MocareHealth
Company
Motex Healthcare(Anhui)Co.,Ltd.
Model
7629S/5.5
Device description
Sterile Polyisoprene Powder-Free Surgical Gloves - Natural
Published
2024-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGOSurgeon'S Gloves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGOSurgeon'S GlovesGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063757000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063757000MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVESShanghai Motex Healthcare Co., Ltd.2007-07-27KGO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36971384153956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697138415395636971384153956

Sterilization Methods#

Method table
Method
Radiation Sterilization

Regulatory Flags#

DUNS number
560080502
Device count
1
Contains natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
26971384150842MocareHealth1610/52021-08-26
26971384150859MocareHealth1610/5.52021-08-26
26971384150866MocareHealth1610/62021-08-26
26971384150873MocareHealth1610/6.52021-08-26
26971384150880MocareHealth1610/72021-08-26
26971384150897MocareHealth1610/7.52021-08-26
26971384150903MocareHealth1610/82021-08-26
26971384150910MocareHealth1610/8.52021-08-26
26971384150927MocareHealth1610/92021-08-26
26971384150934MocareHealth1610/9.52021-08-26
26971384150026MocareHealth7235S2021-08-24
26971384150040MocareHealth7235L2021-08-24
26971384150057MocareHealth7235XL2021-08-24
16971384154829MocareHealth7235-5.5/L2026-04-17
26971384154826MocareHealth7235-5.5/L2026-04-17
36971384154823MocareHealth7235-5.5/L2026-04-17
26971384150019MocareHealth7235XS2020-09-09
16971384153648MocareHealth7521F/52024-08-16
16971384153655MocareHealth7521F/5.52024-08-16
16971384153662MocareHealth7521F/62024-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07333350064938Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350119621Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350176181Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350407926Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350581305Biogel® PI Micro Indicator® SystemMölnlycke Health Care ABKGO2026-10-29
07333350696177Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350861582Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
07333350974121Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-29
07333350999124Biogel® PI Micro Indicator® UndergloveMölnlycke Health Care ABKGO2026-10-29
10809160542125HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
10809160542132HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-10-28
00755676002369mvetADI MedicalKGO2026-10-26
00755676002376mvetADI MedicalKGO2026-10-26
00755676002413mvetADI MedicalKGO2026-10-26
00755676002437mvetADI MedicalKGO2026-10-26
00755676002451mvetADI MedicalKGO2026-10-26
00755676002468mvetADI MedicalKGO2026-10-26
00755676002482mvetADI MedicalKGO2026-10-26
00755676002505mvetADI MedicalKGO2026-10-26
07333350811372Biogel® PI MicroMölnlycke Health Care ABKGO2026-10-20
10809160539026HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-25
10809160538968HalyardMEDICAL ACTION INDUSTRIES INC.KGO2026-09-24
10888277417205MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417212MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417229MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417236MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417243MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417250MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277417267MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03
10888277603516MEDLINEMEDLINE INDUSTRIES, INC.KGO2026-08-03